Status:
COMPLETED
Naproxen Sodium ER Pharmacokinetic Study
Lead Sponsor:
Bayer
Conditions:
Pain
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
To determine the pharmacokinetic profile of the investigational product following dosing under fed conditions.
Eligibility Criteria
Inclusion
- Healthy ambulatory, male and female volunteers between 18-55 years of age with a Body Mass Index (BMI) of approximately 18 to 30kg/m2, and a total body weight \>50 kg (110 lbs)
- Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the principal Investigator and the Sponsor
- Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g oral or patch contraceptives, intrauterine device, NuvaRing, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and Day 0 of each Dosing Period. Female subjects of non childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
- Be willing and able to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the protocol
- Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial
Exclusion
- History of hypersensitivity to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products
- History of gastrointestinal bleeding or perforation, related to previous nonsteroidal anti-inflammatory drug (NSAID) therapy. Active, or history of recurrent peptic ulcer/ hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases or malignancies
- Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (Over the counter (OTC) or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment
- Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)
- Have taken any vitamin or herbal supplement within 7 days prior to dosing or refuse to refrain from use during the trial
- Alcoholism or drug abuse within 2 years prior to the Screening Visit
- Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00818415
Start Date
November 1 2008
End Date
November 1 2008
Last Update
May 19 2014
Active Locations (1)
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1
Austin, Texas, United States, 78744